Research Ethics

While undertaking research at the University I became engaged with ethics, I will admit somewhat unwillingly at first. I accepted nomination to the faculty Ethics Committee (EC) and a few years later became its Chair. My concern was to transform well-intentioned but ad hoc decisions on ethics approval into a structured system that was objective, criterion driven, and fit for purpose. Some years later, while consulting on research projects, I have come to realise that my considerations might have some interest for others, hence this page.

Relevant issues

The first step was the identification of the ethical matters that were relevant to the great majority of the research studies and scholarly investigations in the faculty that were undertaken by undergraduates (term and final year projects), graduates (MSc and PhD theses), and academic staff (research council funded programmes). It turned out that almost all these studies and investigations involved human participants, and that was the starting point.

Informed consent

The first requirement for studies seeking ethics approval was that they should arrange for informed consent. For studies with minimal ethical issues, it was decided that participant information could be given verbally to participants either individually or in one or more groups, and individual consent could in turn be given verbally. For other studies, a consent document was required. This involved hard copy participant information which participants could take away, and two hard copy written consent forms, one copy for the investigator as signed by the participant, and one copy for the participant. The contents of the participant information document were further defined in relation to the particular study characteristics as outlined below.

Then, six ethical issues surrounding human participants were identified. In rough order of significance, these were: Minors; Deception; Risk of harm; Intrusion; Personal or sensitive data; and Inducement.

Minors

If a study might involve a participant under the age of 18, it was required to provide appropriate special arrangements in the consent document. If the application also required, or the study also involved any of the following, appropriate special arrangements were to be made: in a debrief; documented in a risk management plan; documented in any 24/7 contact information; and for any inducement.

Deception

Deception was principally defined as not informing every participant of the true purpose of the study before the study began. If the study involved deception, it was required to provide a debrief. The application was required to justify the nature and necessity of the deception, and to explicitly identify those aspects of the participant information which would need to be revealed as deceptive during the debrief.

Risk of harm

Harm was broadly defined as an adverse effect upon a human's person (and not just upon a participant's person; the intention was to include investigators, study assistants, or study consultants). Risk was classified as insignificant or extant. An insignificant risk was minimal or negligible, unlikely and with low impact if it did occur. Any risk which was not insignificant was extant, and 'risk of harm' meant 'extant risk of harm'. The application required the justification for the risk(s) and a debrief, a risk management plan (RMP), and 24/7 contact information.

Intrusive procedure

An intrusive procedure was conceived as a 'low level' invasive procedure if it involved extant risk of unwelcome effects upon a participant’s privacy, person, or time. For example, if the study involved: wearing a device; questions about matters which would be considered private, such as academic performance; participation for more than one hour. The application required a justification of the intrusive risks, and a debrief.

Personal data

Personal or sensitive data was defined according to the definitions given in the Data Protection Act and the more recent General Data Protection Regulations. Personal data was defined as data contributed or provided by a human, where the data could allow their identification either by itself or in conjunction with other data that might be known. Sensitive data was personal data about a person’s ethnic origins, political opinions, religious beliefs, trade union membership, health, sexual life, or any criminal history. The application required a data protection plan.

Inducement

Inducement was defined as reward or compensation for participation, either explicit (for example, gaining course credit) or implicit (for example, student participants might be led to understand that a better mark for an assignment might be expected). The application was required to justify the inducement.

For a higher authority (coercion, invasive procedure)

There were some ethical issues which were considered to be outside the competence of the faculty committee, and four were identified. Automatic elevation to the University ethics committee would occur for applications involving coercion or invasive procedures, as well as studies involving human tissue or animals. Coercion was defined quite simply as the inability of a participant to withdraw at any time, for any or no reason, and without loss of any inducement as might have been arranged or provided up to that point. An invasive procedure was defined very broadly to involve either physical invasion (introducing instruments or materials into the body or body cavities) or personal invasion of privacy, effort, or time (revealing or discussing private or confidential information; requiring significant effort; or requiring significant time expenditure). An elevated application would return to the faculty ethics committee after approval by the higher authority for further consideration and faculty approval.

Study arrangements

It was clear that there was one key arrangement that always needed to be documented in the application, being the provision of participant information and the associated receipt of informed consent. Then it became clear that (only) four further key arrangements were needed in relation to one or other relevant ethical issue: Debrief; 24/7 contact information; Risk management plan; and Data protection plan.

Debrief

An end-of-study debrief was required if the study involved an invasive procedure, deception, risk of harm, or intrusion. It was required to comprise one or more meetings, appropriately timed, between the investigator(s) and the participants of the study after the completion of data collection.

In a debrief, it was always required to (a) explain the study results and outcomes, (b) acknowledge the contribution of the participants, and (c) make information about the study results and outcomes available to all participants in a suitable form for later reference. Then, further requirements of a debrief depended upon the specific ethical issue.

If the study involved deception, the debrief was required to (a) provide an explanation for it, and (b) be attended by one or more persons appropriately qualified to identify and deal with adverse psychological and physical reactions during and following the debrief.

If the study was intrusive, the debrief was required to provide the contact details of one or more persons appropriately qualified to deal with any unwelcome effects of such intrusion.

If the study involved any risk of harm, the debrief was required to be attended by one or more persons appropriately qualified to identify and deal with such risks.

24/7 contact information

24/7 contact information was required to be provided to participants if the study was invasive or involved coercion or risk of harm. It was defined as (a) information about relevant emergency services and how to contact them, and (b) contact information for the investigator(s) and supervisors (if any) which secured access at any time and on any day.

Risk management plan

A risk management plan (RMP) was required if the study was invasive or involved risk of harm. A 'basic' RMP for a study which involved minors or risk of harm was defined to comprise a list of the extant risk(s) showing their likelihoods, the procedures the study would put in place to minimise and/or manage them, and the escalation procedures the study would follow should they occur. An 'enhanced' RMP for a study which involved any invasive procedure would also include, for each risk, its expected loss value should it occur; its exposure amount being loss value multiplied by likelihood; the cost of its management; and its risk leverage being exposure amount divided by management cost.

Data protection plan

A data protection plan was required if the study involved personal or sensitive data. The plan was required to attest that all personal data processed by the study was accurate, relevant, not excessive, held securely, retained for only as long as necessary, used only for the purposes of the study, and accessible to the participant. The plan was required to describe: the data to be collected including all questions and questionnaires to be asked of the human participants; the processes for ensuring data security; the separation of identifying data and the anonymisation process; the method of linking the consent form (if required) to the participant’s data; and the processes for destruction of data. Finally, the plan was required to Identify the authority which will give participants access to their personal data and provide the relevant contact information.

The application

Apart from addressing specific ethical issues, it was thought that an application for ethical approval needed to provide an outline of three matters: Recruitment; Study methodology; Instruments of data collection, typically questionnaires. The key descriptor here was "outline". It was considered that a short paragraph would be sufficient for the first two matters, and copies of questions and questionnaires would be sufficient for the last.

Only if the study involved 'significant' ethical issues was it thought necessary for detail, explanation, and justification in the application. These 'significant' issues were if the study involved coercion or invasive procedures, or deception, risk of harm, or intrusion. For such a study, the application was required to provide a detailed justification of the study merits, statistical power, design and methodology, and data analysis.

The application form

In laying out the the form of application for approval, it was thought that careful definition and delineation of key concepts would be best expressed in an appendix to the form rather than as they were encountered in the form itself. This would make the application form itself a single sheet (two-sided) document that would facilitate both the process of making an application by the investigator and its review by the committee.

Ethics Committee

Application for Review

Please refer to the definitions of the terms shown in bold, and the instructions which follow the form. The application is to be completed by the investigator(s).

Date of application:

OFFICE USE ONLY
Reference number:
EC___/___/___
[yy/mm/nnn]

Name of investigator(s):

Signature(s):

(Please review the definition of ‘signature’, below.)

Name of supervisor(s) (if applicable):

Signature(s):

(Please review the definition of ‘signature’, below.)

Title of study:

Expected start date:

Expected end date:

		Yes	No
Prelim	Does the study involve participants? If ‘No’, approval for the study may be dealt with by Chair’s Action. Review Note 1 for animals or human tissue.
A	Will every participant be able to withdraw from the study at any time and for any reason? If ‘No’, the study is considered to involve coercion and will be elevated to the University Ethics Committee. Explain in attached pages the necessity for coercion.
B	Is the study invasive? If ‘Yes’, the study will be elevated to the University Ethics Committee. The study is considered to pose a risk of harm to participants which is not insignificant and requires a debrief, a risk management plan enhanced (RMPE), and 24/7 contact information. Explain in attached pages the necessity for the risk(s) listed in the RMPE.
1	Might any participants be minors? If ‘Yes’, special arrangements must be made and explained in the study protocol and in the consent document, and in any debrief, any risk management plan, any 24/7 contact information, and for any inducement, as may be additionally required or relevant.
2	Does the study involve deception of any participant? (Deception includes, but is not limited to, not informing every participant of the true purpose of the study before the study begins.) If ‘Yes’, the study requires a debrief. In addition, explicitly identify those aspects of the participant information which may need to be revealed as deceptive during the debrief, and explain the nature and necessity of the deception on an attached page.
3	Is there any risk of harm to any participant which is not insignificant? If ‘Yes’, the study requires a debrief, a risk management plan (RMP), and 24/7 contact information. Explain in attached pages the necessity for the risk(s) listed in the RMP.
4	Is the study intrusive? If ‘Yes’, the study requires a debrief. Explain in an attached page where the intrusive risks arise and why these risks are necessary.
5	Does the study involve personal data or sensitive data? If ‘Yes’, explain and provide in attached pages the data protection (DPA) plan.
6	Does the study involve inducement to any participant? If ‘Yes’, explain the nature of the inducement (eg course credit) in an attached paragraph.
Consent	Is the answer ‘Yes’ to any of questions A, B, 1, 2, 3, 4, or 5 (coercion, invasive, minors, deception, risk of harm, intrusion, personal data, sensitive data)? If ‘Yes’, provide the consent document. Otherwise, participant information and consent may be given verbally.
Debrief	Does the study require a debrief (an answer of ‘Yes’ to question B, 2, 3, and/or 4, invasive, deception, risk of harm, intrusion)? If ‘Yes’, provide attached pages which explain the debrief procedures. Review Note 2.

Names of EC reviewing members (see Notes 3, 4, and 5): (extend list as required)	Date of approval:
	Signatures:
Instructions 1. The Investigator(s) and any Academic supervisor(s) should complete the form by providing the information required and attaching their signature to indicate that the answers provided are correct, and that they agree to the conditions specified in the definition of ‘signature’. 2. Attach the study protocol. 3. Attach any application additional information. 4. Version number every document.
Notes 1. If the study is invasive (question A), or involves coercion (question B), or involves animals or human tissue, refer to the EC Chair before submission. Such an application will be automatically elevated to the University Ethics Committee and will only return to the EC following UEC approval. 2. The study will have its methodology and scientific or research merit formally reviewed if it involves coercion or is invasive (questions A and B) or requires a debrief (involves deception, risk of harm, and/or intrusion, questions 2, 3, and 4). Otherwise, the EC may offer ‘unofficial’ informal comments on matters of methodology and merit which are intended to be helpful but are not binding. 3. An EC Panel of three members may review an application where the answer is ‘No’ to question 1 (minors). 4. An EC Panel of one member may review an application (‘expedited review’), where the answer is ‘No’ to question 1 (minors) and the study does not require a debrief (does not involve deception, risk of harm, or intrusion, answers are ‘No’ to questions 2, 3, and 4). 5. The EC Chair may review an application (‘Chair’s action’) where the answer is ‘No’ to the Prelim question (participants).

Appendix to application form

In the following definitions, any examples given are indicative but not exhaustive of all possibilities.

Application additional information. Include any required Research Governance Office documentation.
If the study is funded, is part of any funded study, or will be submitted for funding:
—      identify the agency;
—      provide the relevant dates;
—      identify any restrictions imposed by the agency, such as restrictions to publication.
If the study has been, or will be, submitted elsewhere for ethical review:
—      identify the reviewing body;
—      provide the relevant dates;
—      provide the outcome if known.

24/7 contact information. Information about relevant emergency services and how to contact them, and contact information for the investigator(s) and supervisors (if any) which secures access at any time and on any day.

Consent document. A consent document comprises (a) hard copy written participant information which participants must be able to take away if they wish, and (b) two hard copy written consent forms (one copy for the investigator signed by the participant, one copy for the participant to take away).

Consent form. A form giving consent which shall be individually and separately signed by every participant.

Data protection plan. The Data Protection Act requires that all personal data is: accurate, relevant, not excessive, held securely, retained for only as long as necessary, used only for the purposes of the study, and accessible to the participant. The data protection plan must address each of these issues.

In the data protection plan, describe at least: the data to be collected including all questions and questionnaires to be asked of the human participants, making reference to accuracy and relevance; the processes for ensuring data security; the separation of identifying data and the anonymisation process; the method of linking the consent form (if required) to the participant’s data; and the processes for destruction of data. Identify the authority which will give participants access to their personal data (this is the School or Faculty Office, provide the contact information).

Debrief. One or more meetings, appropriately timed, between the investigator(s) and the participants of the study after the completion of data collection. The debrief shall explain the study results and outcomes, and acknowledge the contribution of the participants. Information about the study results and outcomes shall be made available to all participants in a suitable form for later reference.

If the study involved deception, the debrief shall provide an explanation for it, and shall be attended by one or more persons appropriately qualified to identify and deal with adverse psychological and physical reactions during and following the debrief.
If the study was intrusive, the debrief shall provide the contact details of one or more persons appropriately qualified to deal with any unwelcome effects of such intrusion.
If the study involved any risk of harm which was not insignificant, the debrief shall be attended by one or more persons appropriately qualified to identify and deal with such risks.

Harm. Adverse effects upon a human’s person.

Inducement. Reward or compensation for participation, either explicit (eg money, book tokens, gift vouchers; gaining course credit) or implicit (eg students understand, ‘if you help me I’ll help you’; a better mark for an assignment may be reasonably expected).

Insignificant: See the definition of risk.

Intrusive/intrusion. The study is intrusive and involves intrusion if there is extant risk of unwelcome effects upon a participant’s privacy, person, or time. (For example, the study involves: wearing a device; questions about matters which would be considered private, such as academic performance; participation for more than one hour.)

Invasive. Introducing instruments or materials into the body or body cavities; revealing or discussing private or confidential information; requiring significant effort or time expenditure. (For example, the study involves: taking tablets; measuring body temperature; questions about medical history; completing a 20-minute video diary every day for two weeks.) A study which involves invasive procedures is considered to always involve extant risk of harm and to always be intrusive.

Investigator(s). The person(s) carrying out the study. Student investigator(s) shall fall under the academic supervision of at least one named member of Academic staff.

Minor. Participant under the age of 18.

Participants. Subjects of the study, either humans (including their tissues or organs) or personal data, or both.

Participant information. If the study does not require a consent document then participant information may be given verbally to participants in one or more groups, and their consent may be given verbally. At the least, the participant information shall explicitly mention the EC reference number (xx/xx/xxx), inform the participant of their right to unconditionally withdraw at any time and for any reason, and (if applicable) shall explain their right to retain any inducement following withdrawal.
If the study involves personal data, the participant information shall provide information in an appropriate way on the data protection plan and its relevance to the participant.
If the study involves intrusion, the participant information shall describe the study purpose and procedures, and it shall provide contact information for the investigator(s) and the academic supervisor to be reached during normal working hours.
If the study involves any risk which is not insignificant, the participant information shall provide 24/7 contact information.

Personal data. Data contributed or provided by a human, where the data could allow their identification either by itself or in conjunction with other data that might be known. This definition corresponds with the definition of ‘personal data’ in the Data Protection Act. If the study involves personal data, the consent document is required for each participant. (For example, a study might process data about a person’s age. If in the group of participants there was only one person aged 50, with all others aged between 18 and 25, that person could be uniquely identified by someone with knowledge of the group concerned. This study thus involves personal data because of the possibility of identification of an individual. Note that this possibility, though perhaps considered unlikely during planning, could not be ruled out in advance, and hence the study must be presumed to involve personal data when applying for ethical review.) (For example, a study may ask its participants to rate a computer interface on a number of dimensions of usability using a scale of 1..5, and may ask no other questions nor collect any other data. This study does not involve any personal data, and, by design, has no possibility of involving personal data.)

Risk. For the purposes of ethical review, risk is classified here into two categories: Insignificant: A low-level risk, unlikely and with low impact if it does occur. Sometimes called ‘minimal’ or ‘negligible’. Extant: Any risk which is not insignificant.

Risk management plan (RMP). A table of the extant risk(s) to participants. The table lists all such risks, showing their likelihoods, the procedures the study will put in place to minimise and/or manage them, and the escalation procedures the study will follow should they occur. A Risk Management Plan Enhanced (RMPE) shall also include the following information for each risk: its expected loss value should it occur; its exposure amount being loss value multiplied by likelihood; the cost of its management; and its risk leverage being exposure amount divided by management cost.

Sensitive data. This is personal data about a person’s ethnic origins, political opinions, religious beliefs, trade union membership, health, sexual life, or any criminal history.

Signature. Attestation that the person concerned will:
1.              Conduct the study in accordance with the information declared on the form;
2.              Conduct the study in accordance with University policy governing research involving human participants;
3.              Submit the study for re-review if any changes, circumstances, or outcomes affect the answers given to the questions on the form;
4.              Promptly advise an appropriate authority of any adverse study outcomes, changes, or circumstances;
5.              Seek EC advice in the event of material changes to the submitted study documentation following approval;
6.              Submit an end-of-study form if required by the Research Governance Office upon completion of the study.

Study. A proposal for work to be carried out by investigator(s).

Study protocol. A full and detailed statement of the procedures of the proposed study,
1.       Including:
—      A description of the participants and their recruitment;
—      A description of the study methodology and procedures including their expected durations;
—      Copies of questionnaires and/or details of other study instruments;
—      The participant information to be given to the participants
        or
       The Consent document if question A, B, 1, 2, 3, 4, or 5 was answered ‘Yes’ (coercion, invasive, minors, deception, risk of harm, intrusion, personal data, sensitive data).
—      The Debrief if question B, 2, 3, or 4 was answered ‘Yes’ (invasive, deception, risk of harm, intrusion).
—      The 24/7 contact information if question A, B, 1, or 3 was answered ‘Yes’ (coercion, invasive, minors, risk of harm).
—      The Risk management plan if question 1 or 3 was answered ‘Yes’ (minors, risk of harm).
—      The Risk management plan enhanced if question B was answered ‘Yes’ (invasive).
—      The Data protection plan if question 5 was answered ‘Yes’ (personal data, sensitive data).
2.       If the study is invasive or involves coercion, deception, risk of harm, or intrusion (question A, B, 2, 3, or 4 was answered ‘Yes’), provide:
—      An outline of the merits of the study (scientific, research, societal);
—      A description of the study design (experimental, observational);
—      Statistical power calculation(s);
—      Justification of samples (intact, opportunity, random); and
—      An explanation of how the data will be analysed.